N/A N=5

Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors

Lung Cancer · Prostate Cancer · Bladder Cancer · Thymic Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02233842 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2016

Primary outcome: Primary: Number of Participants to Achieve Saturation in an English-language Paper Questionnaire — 30 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Participant interview (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants to Achieve Saturation in an English-language Paper Questionnaire	30	—
PRIMARY Number of Smokers at the Time of the Interview	6; 23; 1	—
PRIMARY Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis	6; 6	—
PRIMARY Time From Cancer Diagnosis to the Date of the Interview	3	—

Summary

Background: - People who have cancer have more medical problems if they smoke. Some studies show that smoking even makes cancer treatment less effective. Researchers want to teach people about how tobacco use affects people after a cancer diagnosis. They want to come up with questions for people who have cancer and who have survived cancer. The questions will be about using cigarettes and other tobacco products and about second-hand smoke. The questions will be used to understand how using tobacco affects people with cancer before, during, and after treatment. This will help doctors plan how to treat people with cancer and create programs to help people quit smoking in the future. Objective: - To evaluate and refine questions that assess tobacco use. Eligibility: - Adults age 21 or older who have cancer or are cancer survivors. The cancer can be at any site and any stage. Design: * This study will take about 1 hour. * Participants will meet one-on-one with an interviewer. They will fill out a questionnaire and talk about the questions. Participants will explain how easy or hard it was to answer the questions and how they decided on their answers. * All participants will be asked the same or very similar questions. Specific questions will be based on the participants own experiences with tobacco products. * There will be no follow-up activities.

Eligibility Criteria

INCLUSION CRITERIA:

Patients with any prior confirmed cancer diagnosis being treated or followed at the Center for Cancer Research, Bethesda, Maryland, will be eligible.

3.1.1 Cancer patients with any disease site, stage, and extent of prior therapy will be eligible.

3.1.2 Patients age 21 years old and over will be eligible. The items are intended for use with an adult population, so we need to test with representatives of that population.

3.1.3 Additional eligibility criteria:

Individuals must be able to understand and willing to answer items about their own tobacco use.
Individuals must be able to read and speak English. For purposes of this study, we will limit participation to adults who can self-consent and self-report in English (vs. only being able to respond with the aid of a translator). The materials have been developed in English; this is intended to be cognitive testing of an English language questionnaire. (If a Spanish translation of the items will be developed in the future, a separate cognitive testing effort will be needed to ensure cultural equivalence of the items.)

3.1.4 Participants must be able to understand and be willing to sign a written informed consent

document. All participants will be asked to provide explicit consent.

3.1.5 Participants are eligible whether they have never used tobacco products of any type, used any type of tobacco previously, or are current tobacco users of any type. (Participant recruitment will be designed to enroll a variety of patients with respect to tobacco use.)

EXCLUSION CRITERIA

None. (Patients may have already begun protocol treatment.)

INCLUSION OF WOMEN AND MINORITIES:

Both men and women of all races and ethnic groups are eligible for participation in testing of the items. In fact, to the extent possible, we will try to include diversity of demographic characteristics (age, race, gender, education level).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02233842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.